A Phase III Trial of e-TNS for the Acute Treatment of Migraine

The main objective of this study is to have Phase III evidences of the efficacy of the
Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as
triptans are generally used. That is to say having randomized, double-blind, sham-controlled
data of the efficacy and safety of the Cefaly® Abortive Program device in the abortive
treatment of acute migraine as measured by 2-hour pain freedom, pain relief and
migraine-associated symptoms freedom, plus evolution of these measurements for 24 hours after
the beginning of the treatment session.

Inclusion Criteria:

1. Age from 18 to 65 on the day of signing the informed consent form

2. ≥ 1-year history of migraine with or without aura according to the diagnostic criteria
listed in ICHD-III beta (2013) section 1, migraine, with the exception of aura without
headache, hemiplegic migraine and brainstem aura migraine

3. Migraine onset before the age of 50

4. Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in
each of the two months prior to screening

5. Patient understands the study procedures, alternative treatments available, and
voluntarily agrees to participate in the study by giving written informed consent

6. Patient is able to read and understand the written information (instruction sheet,
paper diary and AE reporting form)

Exclusion Criteria:

1. Patient has difficulty distinguishing his/her migraine attacks from tension-type
headaches

2. Patient has more than 15 headache days per month

3. Patient having received supraorbital nerve blocks in the prior 4 months

4. Patient having received Botox treatment in the prior 4 months

5. Modification of a migraine prophylaxis treatment in the previous 3 months

6. Diagnosis of other primary headache disorders, except rare (< 4) tension-type
headaches per month

7. Diagnosis of secondary headache disorders including Medication Overuse Headache

8. Patient abusing opioids or user of recreational or illicit drugs or having had a
recent history (within the last year) of drug or alcohol abuse or dependence

9. Implanted metallic or electronic device in the head

10. Cardiac pacemaker or implanted or wearable defibrillator

11. Patient having had a previous experience with the Cefaly® device

12. Migraine Aura without headache

13. Patient is currently participating or has participated in a study with an
investigational compound or device in the last 30 days before the screening visit
(Visit 1)

14. Patient not having the ability to use appropriately the device and/or to perform
himself/herself or bear the first 20-minute stimulation session during the training
test session at the study site